510(k) K163645
- Device
- DERMABOND PRINEO Skin Closure System
- Applicant
- Ethicon, LLC
- 510(k) number
- K163645
- Product code
- OMD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-04-21
- Date received
- 2016-12-23
- Regulation
- 878.4011
- Classification name
- Cutaneous Tissue Adhesive With Mesh
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Joice Pappan
- Address
- Rte. 22 W. P.O. Box 151 Somerville NJ US 08876 08876
FDA Registration Numbers#
- 1061124
- 3004530184
- 1064858
- 2210968
- 3013188547
- 3017102971
- 3010034760
- 1319639
- 3013403214
- 2648650
- 9617175
- 3031294900
Source Documents#
Other 510(k) Records For Product Code OMD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233460 | CM00622 LINC Skin Closure System (CM00622 LINC) | Connexicon Medical , Ltd. | 2024-07-15 |
| K211878 | LiquiBand XL | Advanced Medical Solutions Limited | 2022-05-23 |
| K213512 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | 2021-12-07 |
| K191461 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2020-06-05 |
| K171442 | Exofin Fusion Skin Closure System | Chemence Medical, Inc. | 2017-09-25 |
| K152490 | DERMABOND PRINEO Skin Closure System | ETHICON, Inc. | 2015-11-25 |
| K133864 | DERMABOND PRINEO SKIN CLOSURE SYSTEM | ETHICON, Inc. | 2014-03-10 |
| DEN090005 | PRINEO SKIN CLOSURE SYSTEM | Closure Medical Corp. | 2010-04-30 |
Legacy Summary#
summary
FDA Review#
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